Caliper Life Sciences Provides Labchip Platform To FDA

Caliper Life Sciences presented the benefits of the LabChipGX platform for high throughput screening and characterization assays for biological drugs at a training session for reviewers from the FDA.

Caliper invited scientists from Pfizer, Amgen and Biogen Idec to describe their analytical approaches for biologics characterization. They described an industry-wide need for analytical techniques that provide high throughput, predictive assessments of biological product quality. Caliper said that this need is being addressed by its LabChip GX platform, which provides high resolution analytical data on a time scale that is approximately 70 times faster than conventional capillary electrophoresis.

Kevin Hrusovsky, CEO of Caliper Life Sciences, said: “We were pleased to accept the FDA’s invitation to present our LabChip platform to a large group of reviewers. We believe that platform will accelerate the adoption of quality-by-design approaches that ultimately will improve the safety profiles of new biologics and vaccines.

“Additionally, our discussions with FDA officials indicate that Caliper’s LabChip platform may have applications for downstream manufacturing release assays and potentially as an inline quality control technique.”